Focus on Imports FDA Food Safety Modernization Act

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Focus on ImportsFDA Food Safety Modernization
Act
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Food Safety Modernization Act

• I thank the President and members of
  Congress for recognizing that the burden that
  foodborne illness places on the American people
  is too great, and for taking this action.
• Margaret A. Hamburg, M.D.,
• Commissioner of Food and Drugs

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Agenda

• The public health imperative
• Why is the law needed?
• Provisions of the law focus on imports
• Implementation

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The Public Health Imperative

• Foodborne illness is a significant burden
• About 48 million (1 in 6 Americans) get sick each
  year
• 128,000 are hospitalized
• 3,000 die
• Immune-compromised individuals more susceptible
• Infants and children, pregnant women, older
  individuals, those on chemotherapy
• Foodborne illness is not just a stomach acheit
  can cause life-long chronic disease
• Arthritis, kidney failure

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Why is the law needed?

• Globalization
• 15 percent of U.S. food supply is imported
• Food supply more high-tech and complex
• More foods in the marketplace
• New hazards in foods not previously seen
• Shifting demographics
• Growing population (about 30) of individuals are
  especially at risk for foodborne illness

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Main Themes of the Legislation
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Import Safety Most Groundbreaking Shift

• Current reliance on port-of-entry inspection
  cannot handle increase in imported food.
• Importers now responsible for ensuring that their
  foreign suppliers have adequate preventive
  controls in place
• Requires food from abroad to be as safe as
  domestic

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Import Safety Mandates

• Sec. 301. Foreign supplier verification program
• Requires importers to verify their suppliers use
  risk-based preventive controls that provide same
  level of protection as U.S. requirements.
• Sec. 302. Voluntary qualified importer program
• Allows for expedited review and entry facility
  certification required
• Sec. 303. Certification for high-risk food
  imports
• FDA has discretionary authority to require
  assurances of compliance for high-risk foods

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Import Safety Mandates

• Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be
  added to prior notice submission
• Sec. 305. Capacity building
• FDA mandate to work with foreign governments to
  build food safety capacity
• Sec. 306. Inspection of foreign food facilities
• Can deny entry if FDA access for inspection is
  denied
• Sec. 201. Targeting of inspection resources
• Increased inspection of foreign as well as
  domestic facilities

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Import Safety Mandates

• Sec. 307. Accreditation of third-party auditors
• FDA can rely on accredited third parties to
  certify that foreign food facilities meet U.S.
  requirements
• Sec. 308. Foreign Offices of the Food and Drug
  Administration.
• Establish offices in foreign countries to provide
  assistance on food safety measures for food
  exported to the U.S.
• Sec. 309. Smuggled Food
• In coordination with DHS, better identify and
  prevent entry of smuggled food

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Role of Third-Party Certification Programs

• Tool for importers to obtain needed assurances to
  meet their obligations for the foreign supplier
  verification program (sec. 301)
• A way for importers to participate in the
  voluntary qualified importer program to expedite
  movement of food through the import process (sec.
  302)
• Can be required by FDA to accompany high-risk
  foods (sec. 303)

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Import Provisions Work as a Whole
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Enhanced Partnerships Vital to Success

• International capacity building
• FDA has mandate to work with foreign governments
  to build their food safety capacity
• Allows FDA to rely more heavily on foreign
  government oversight
• Capacity building helps to prevent problems
  before products reach the U.S. port of entry

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Trade Agreements

• Section 404, Compliance with International
  Agreements, explicitly notes that FSMA must be
  consistent with our agreement with the World
  Trade Organization (WTO) and any other treaty or
  international agreement. 
• At each stage of the implementation process, we
  will make every effort to ensure that our
  proposed activities, policies, and measures are
  consistent with the WTO. 

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Implementation Approach

• Implementation already underway
• Coalition needed
• Transparency a priority
• Focus on public health protection
• Engage with stakeholders to help determine
  reasonable and practical ways to implement
  provisions

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But, many challenges

• Enormous workload
• - 50 new rules, guidance documents, reports in 3
  years
• Tight deadlines
• Changes wont appear overnight
• - Building new system will be a long-range
  process
• Resources

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Import Projects Completed (as of July 2011)

• Sec. 304. Prior notice of imported food shipments
• Requires information on prior refusals to be
  added to prior notice submission
• Effective July 3, 2011
• Sec. 309. Anti-Smuggling Strategy
• Issued July 3, 2011
• Issued July 3, 2011

• Updated list and more information can be found at
  http//www.fda.gov/fsma

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Outreach

• Public Meeting on Imports
  (March 29, 2011)
• Public Hearing on Comparability and Import
  Practices (March 30-31, 2011)
• 40 listening sessions, meetings to date
• Foreign government outreach through embassy
  briefings

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Rulemaking Process

• Rulemaking is open and public.
• Draft rules are published on http//www.regulation
  s.gov.
• Time is allowed for public comment, and FDA is
  required to consider significant comments during
  the rulemaking process.
• Check http//www.fda.gov/fsma to find out what is
  open for comment.

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Snapshots of sections of the FSMA homepage found
at http//www.fda.gov/fsma
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For more information

• Web site is at http//www.fda.gov/fsma
• Subscription feature available
• Send questions to FSMA_at_fda.hhs.gov